EMA “AZ Vaccine Benefits Outweigh the Risk … Safe and Effective” (3 reports in total)

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The European Medicines Agency (EMA) reported on the 18th (local time) that blood clots formed in some of those who received the new vaccine against coronavirus infection (Corona 19) from the multinational pharmaceutical company AstraZeneca (AZ), and the benefit of this vaccine is at risk of side effects. He said it is greater than.

According to Reuters, AP and AFP, EMA held an extraordinary meeting of the security committee on the same day to conclude on the information collected so far, and then revealed the results of the investigation.

The EMA is responsible for the evaluation and approval of pharmaceuticals and vaccines in the European Union (EU).

EMA Commissioner Emma Cook said at a press conference that day, “the committee has come to a clear scientific conclusion” and “this is a safe and effective vaccine.”

“The committee concluded that this vaccine was not associated with an overall increased risk of blood clots,” he said.

However, Cook said that “the association of this vaccine with certain very rare types of blood clots cannot be clearly ruled out” and recommended adding explanations of these cases to the vaccine information so that patients and healthcare workers can to be informed.

In this sense, the EMA pointed out that the vaccine may have been associated with very rare cases of thrombosis related to thrombocytopenia, referring to cerebral venous thrombosis and disseminated intravascular coagulation.

The EMA added that the causal relationship with the vaccine has not been proven, but that it is possible, even if it is extremely small, and that further analysis is needed.

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Commissioner Cook explained that of the 20 million people who received the vaccine in the United Kingdom and the European Economic Area (EEA), there were 25 such rare cases, nine of which died. Most of these cases were women under 55 years of age.

In a pre and post approval study of the vaccine, the EMA found that 469 cases of blood clots were reported among those who received the vaccine in these areas during the vaccination process, which was less than expected in the general population.

EMA added that there is no evidence of problems with the specific manufacturing unit or the specific manufacturing site of the vaccine.

“We have safe and effective vaccines,” Cook said. “We need to use these vaccines” when asked if countries should resume vaccination against AstraZeneca. He also said: “If it was, they would give me the vaccine tomorrow.”

Recently in Europe, following reports of blood clots in some who received the AstraZeneca vaccine, countries such as Austria, Germany, France, and Italy have temporarily suspended vaccination for a specific manufacturing unit or the entire AstraZeneca vaccine as a preventive measure.

The World Health Organization (WHO) also recommended that AstraZeneca continue vaccination on the 17th, saying the benefits of the Corona 19 vaccine outweigh the risks.

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